NIPRO Diagnostics True Metrix Pro - References

9. CLSI POCT12-A3 Point of Care blood glucose
testing in acute and chronic care facilities;
Approved Guideline – Third Edition,
January 2013.
10. International Organization for Standardization.
In vitro diagnostic test systems. Requirements
for blood-glucose monitoring system for self
testing in managing diabetes mellitus.
Reference number ISO 15197:2013 (E).
Geneva: International Organization for
Standardization; 2013.
11. Good Laboratory Practices for Waived Testing
sites. [Electronic Version]. Retrieved July 14,
2008: www.cdc.gov/mmwr/preview/mmwrhtml/
rr5413a1.htm.
TRUE METRIX
®
PRO System Comprehensive Resource Guide (GDH-FAD Enzyme) References 43
References
1. FDA Public Health Notification: Use of Fingerstick
Devices on More than One Person Poses Risk
for Transmitting Blood Borne Pathogens: Initial
Communication Update 11/29/2010 [Electronic
Version]. Retrieved February 22, 2012 from
http://www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/ucm224025.htm.
2. CDC Clinical Reminder: Use of Fingerstick
Devices on More Than One Person Poses Risk for
Transmitting Bloodborne Pathogens [Electronic
Version]. Retrieved February 22, 2012 from
http://www.cdc.gov/injectionsafety/Fingerstick-
DevicesBGM.html.
3. International Organization for Standardization.
In vitro diagnostic test systems. Requirements
for blood-glucose monitoring system for self-
testing in managing diabetes mellitus. Reference
number ISO 15197:2003 (E). Geneva: International
Organization for Standardization; 2003.
4. Data on file.
5. U.S. Food and Drug Administration.
Blood Glucose Meters, Getting the Most
Out of Your Meter. [Electronic Version].
Retrieved July 6, 2009: www.fda.gov/
MedicalDevices/Safety/ AlertsandNotices/
TipsandArticlesonDeviceSafety/ucm109371.htm.
6. Larsson-Cohn U: Difference between capillary
and venous blood glucose during oral glucose
tolerance tests. Scand J Clin Lab Invest 36:805-
808, 1976.
7. Atkin, S.H., et. al. Fingerstick Glucose
Determination in Shock. Annals of Internal
Medicine, 114:1020-1024 (1991).
8. Clinical and Laboratory Standards Institute.
Interference Testing in Clinical Chemistry;
Approved Guideline—Second Edition. CLSI
document EP7-A2 [ISBN 1-56238-584-4]. Clinical
and Laboratory Standards Institute, 940 West
Valley Road, Suite 1400, Wayne, Pennsylvania
19087-1898 USA, 2005.